Kornimate/medical-research-clean huggingface dataset:
nodal upstaging in vats anatomical resections for nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study investigates peropeative nodal upstaging during anatomical resections for non-small-cell-lung-cancer in an era of rising numbers of vats anatomical resections. in case of comparable study groups, unchanged pretreatment staging and equal quality of pathologic examination, lymph node upstaging is a marker of surgical quality and can be used to study the quality of a new surgical technique.

vats lobectomy is becoming the standard of care for early stage lung cancer. several studies have shown feasibility and safety in dedicated centres. compared to thoracotomy the procedure is believed to achieve equal oncologic results and survival, perhaps better. publications have shown that mediastianal lymph node dissection during vats is similar. however, two recent reports have shown potential lower n1 (hilar and intrapulmonary) upstaging in vats surgery after optimal staging the percentage of unforeseen n+ the percentage of unforeseen positive nodes can reach 15% nodal upstaging at final pathology is dependent on the quality of: * pretreatment staging, the better, the less upstaging * surgery, ie mediastinal, hilar and intrapulmonary lymphadenectomy * pathologic examination if we accept that pretreatment staging and pathologic examination are equal in two comparable surgical cohorts, the finding of unforeseen n+ or nodal upstaging is a quality marker of surgery. when surgical techniques are changing, it is important to look at this marker. in absence of a randomized trial, we believe a cohort analysis is useful. by including all patients, open or vats, and comparing cohorts instead of the surgical technique used, the selection bias is absent. we compare three cohorts. in the first (20007-2009) almost all patients where operated through a thoracotomy. in a second cohort, (2010-2011) the experience with vats was early. in the third period (2012-2013), a standardized vats technique with extensive intrapulmonary and mediastinal lymphadenectomy was used.

Eligibility criteria:
inclusion criteria: * all cn0, cn1 patients that underwent segmentectomy, lobectomy, sleeve lobectomy for nsclc. exclusion criteria: * cn2 * cm+ * pneumonectomy * previous lung cancer surgery - lymphadenectomy * neo-adjunvant therapy * lung tx * bilateral lesions

Keywords: lymph node excision thoracic surgical procedures thoracic surgery, video-assisted thoracotomy
a phase 3 study to assess the efficacy and safety of pk101 in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare the efficacy and the safety of pk101 in patients with knee osteoarthritis.

the primary purpose of this study is to evaluate the efficacy of pk101 compared with pk101-002 at week 8 in osteoarthritis. also evaluates the safety of pk101.

Eligibility criteria:
inclusion criteria: * patients ≥40 and of age * patients who meets the american college rheumatology (acr) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis. * radiographic evidence of grade 1 \~ 3 osteoarthritis based on the kellgren \& lawrence radiographic entry criteria at visit 1 * score of 100mm pain vas ≤ 80mm at visit 1 * written consent form voluntarily * score of 100mm pain vas ≥ 40mm at visit 3 * patients with an individual medication compliance of 70% or more of the ip administered during the run-in period exclusion criteria: * patients who has a history of hypersensitivity to components of ip, nsaids including cox-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides * patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis * patients with a condition that can affect the joints * patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period * patients who have used corticosteroids as follows: * inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1 * oral corticosteroid administration within 1 month prior to visit 1 * patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1
sirt for potentially resectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this study is conducted to evaluate the efficacy and safety of y-90 selective internal radiation therapy (sirt) in patients with potentially resectable hepatocellular carcinoma (hcc).

this is a bi-center, prospective study to evaluate the efficacy and safety of sirt in patient with potentially resectable hcc. 35 patients with potentially resectable (initially unresectable) hcc will be enrolled in this study. the patients will receive 1-2 sessions of sirt. if the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. if the patients are evaluated as resectable during follw-up, liver resection will be recommended. the primary end point of this study is success rate of conversion to resection. the secondary endpoints are objective response rate (orr), disease control rate (dcr), progression-free survival (pfs), time to progression (ttp), duration of response (dor), overall survival (os) and adverse events (aes).

Eligibility criteria:
inclusion criteria: * hcc with diagnosis confirmed pathologically or clinically * no pervious treatment for hcc * at least one measurable intrahepatic target lesion * potentially resectable hcc: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein * disease amenable to sirt (after evaluation) * child-pugh class a or without cirrhosis * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 * patients with active hepatitis b are allowed, but they need to receive antiviral treatment to achieve a hbv dna\<10\^3 iu/ml * patients with hepatitis c need to finish the anti-hcv treatment * adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/l, white blood cell count \>3.0×10\^9/l, absolute value of neutrophils \>1.5×10\^9/l, hemoglobin ≥85 g/l, asl and ast≤5×uln, creatinine≤1.5×uln, inr\<1.5 or pt/aptt normal range * life expectancy of at least 6 months exclusion criteria: * tumor involving main portal vein, bilateral branches of portal vein, or vena cava * tumor extention beyond one lobe of the liver * bilobar tumor distribution * extrahepatic metastasis * decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy * organ (heart, kidney) dysfunction * hbsag and anti-hcv antibody positive concurrently * history of malignancy other than hcc * uncontrolled infection * history of hiv * history of organ and cell transplantation * patients with bleeding tendency

Keywords: hepatocellular carcinoma unresectable selective internal radiation therapy
prenatal screening for imprinting anomalies implicated in beckwith wiedemann and silver russell syndromes

Conditions: Pregnant Women Requiring Amniocentesis

Summary: losses of imprinting are involved in various syndromes. those occurring in the 11p15 region lead to beckwith-wiedemann and silver-russell syndromes. these losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available dna in amniotic fluid. thus, in spite of growing demand, prenatal diagnosis (pnd) for imprinting abnormalities of the 11p15 region is not available. the recent development of a quantitative pcr method that permits the methylation index (mi) of imprinted regions to be calculated renders pnd technically possible. nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

to evaluate the agreement between the methylation index of the 11p15 region obtained using dna extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (icc). ancillary study : this second part of the study aims to determine the standard of methylation index of the 11p15 region (inclusion of 100 additional patients). the use of amniotic liquid will allow to calculate : * the average of methylation index, * the value of the standard deviation * the inter-assay coefficient of variation for the test-used.

Eligibility criteria:
inclusion criteria: * pregnant women, 18 years of age or older * requiring amniotic fluid sampling in the context of pregnancy care after 15 weeks of amenorrhea * having provided written informed consent * followed at trousseau hospital or clinique des bluets during their pregnancy * covered by or beneficiary of a state health insurance program (except for medical aid programs) exclusion criteria: * warning signs on ultrasound that require a medical termination of pregnancy to be discussed even before amniocentesis is performed

Keywords: mi amniocentesis cord blood placenta silver russell syndrome beckwith wiedemann syndrome
a study of the safety and efficacy of omarigliptin (mk-3102) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin (mk-3102-016)

Conditions: Type 2 Diabetes Mellitus

Summary: this trial will assess the safety and efficacy of omarigliptin (mk-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. the primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin a1c (a1c) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus * on a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control * females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * treated with any antihyperglycemic agents (aha) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent * on a weight loss program and is not in the maintenance phase or has started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation * medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis b or c, primary biliary cirrhosis, or symptomatic gallbladder disease * human immunodeficiency virus * new or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months * history of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) * pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug

Keywords: diabetes
a dose-range finding study for alx-0061 combination therapy in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy and safety of dose regimens of alx-0061 administered subcutaneously (s.c.) in combination with methotrexate (mtx) to subjects with active rheumatoid arthritis (ra) despite mtx therapy, compared with placebo. to assess the effects of alx-0061 on quality of life, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of alx-0061, and to define the optimal dose regimen for alx-0061, based on safety and efficacy, for further clinical development.

subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (sjc) and/or tender joint count (tjc) at week 24 of study alx0061-c201 were invited to participate in an open-label extension (ole) study alx0061-c203 (nct02518620), if the study was approved in their country and selection criteria were met.

Eligibility criteria:
inclusion criteria: * diagnosis of ra for at least 6 months prior to screening, and american college of rheumatology (acr) functional class i-iii * subjects treated with and tolerating mtx * active ra * others as defined in the protocol exclusion criteria: * have been treated with disease-modifying antirheumatic drugs (dmards)/systemic immunosuppressives other than mtx. * have received approved or investigational biological or targeted synthetic dmard therapies for ra less than 6 months prior to screening. * have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic dmards, for ra. * have received prior therapy blocking the interleukin-6 (il-6) pathway, at any time. * others as defined in the protocol
imaging histone deacetylase in the heart

Conditions: Heart Failure With Normal Ejection Fraction; Left Ventricular Hypertrophy; Aortic Valve Stenosis; Diabetes

Summary: the overall goal of this pet-mr imaging trial is to evaluate 11c-martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers.

histone deacetylases (hdacs), a class of epigenetic enzymes, play an important role in the pathophysiology of heart failure, including development of left ventricular hypertrophy and myocardial fibrosis. preclinical data demonstrate the importance of hdac inhibition in attenuating these pathological processes and maintaining the integrity of the myocardium. however, the role of hdacs in the human heart, and the utility of hdac inhibition remains unknown. therefore, a noninvasive method to detect hdac activity in the human heart in healthy individuals and patients with heart disease may be of major medical and public health value to help determine prognosis, direct therapy, and guide the development of novel therapies for heart failure. the investigators have recently developed a novel radiotracer, 11c-martinostat, which binds with high affinity to class i hdacs. the objective of this protocol is to assess the utility of 11c-martinostat pet-mr to detect hdac expression in the hearts of healthy individuals and patients with severe aortic stenosis or diabetes.

Eligibility criteria:
inclusion criteria: group 1: healthy volunteers (n = 30) * healthy adults with no known history of medical disease * age 18-85 years * no history cardiovascular disease * ability to provide informed consent group 2: patients with diabetes (n = 16) * age 18-85 years * diagnosis of diabetes * echocardiogram within last 12 months showing no evidence of left ventricular hypertrophy or hemodynamic findings consistent with heart failure with preserved ejection fraction * ability to provide informed consent group 3: patients with aortic stenosis (n = 50) * age 18-85 years * echocardiogram or cardiac mri scan within last 12 months documenting left ventricular hypertrophy and degenerative calcific aortic stenosis * ability to provide informed consent exclusion criteria: * known contraindication to mri
effects of micronized trans-resveratrol treatment on polycystic ovary syndrome (pcos) patients

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: the purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (pcos).


Eligibility criteria:
inclusion criteria: * pco - androgen excess society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone \>70ng/dl) and/or oligomenorrhea (\<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound * normal prolactin, tsh, 17-oh progesterone * no evidence of androgen producing malignancy, cushing's syndrome or acromegaly * age 18-40 exclusion criteria: * use of oral contraceptives and/or other steroid hormones 3 months prior to the study
rim plate to buttress plate for posterior wall acetabular fractures with and without inter-fragmentary screws

Conditions: Acetabular Fracture

Summary: the hypothesis of this study is that the rim plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.

study type: interventional estimated enrollment: 60 allocation: block randomization. the block randomization method is designed to randomize subjects into groups that result in equal sample sizes. this method is used to ensure a balance in sample size across groups over time. interventional model: parallel assignment description: two different methods of screw and plate fixation of posterior wall acetabulum fractures. time perspective: prospective population: skeletally mature patients who have presented with an acute traumatic fracture of the posterior wall of acetabulum due to dislocation of the femoral head will be included in this study. all surgeons on the study routinely perform both types of repairs. treatment arms and intervention: arm a: rim plate group - this group will consist of 30 patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate. arm b: buttress plate group - this group will consist of 30 patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.

Eligibility criteria:
inclusion criteria: 1. skeletally mature males and females, ≥ 18 years old and with age less than 65 years. 2. fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and ct scan 3. operative fixation of fractures within 14 days of presenting to the emergency room. 4. patient was ambulatory prior to fracture, with or without walking aids 5. medically optimized for operative intervention 6. provision of informed consent by patient or legal guardian. exclusion criteria: 1. patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). 2. pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum. 3. patients with metabolic bone disease including diagnosis of osteoporosis. 4. patients with bony or soft tissue infections around the acetabulum. 5. patients unable to provide informed consent. 6. patients having other fractures of pelvis or acetabulum other than an isolated posterior acetabular wall fracture. 7. patients with previous history of acetabular fracture (operative or nonoperative) 8. patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, legg-calve perthes disease, or advanced degenerative arthritis.
multi-center study of the ndo surgical plicator utilizing multiple implants for the treatment of gerd

Conditions: GERD

Summary: the purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of gerd. a prospective, multi-center, open-label trial was conducted at four centers in germany to evaluate a modified plicator technique for the treatment of patients with symptomatic gerd. primary efficacy was based on analysis of the gerd health related qualify of life (hrql) questionnaire at 6-months post-treatment. additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (vas) score, gerd medication use, esophageal ph/manometry, and esophagitis. trial sample size was chosen to provide 87% power in detecting a 50% median reduction in gerd-hrql score at an alpha level of 0.05.


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * history of heartburn or regurgitation for at least 6 months. * esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (les) of at least 5 mm hg. * ph study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of ph\ 4.5% or a demeester composite score \> 14.7). * symptoms requiring daily ppi therapy. * gerd-hrql scores must be \> 15 while off medication and off medication scores must be \> 6 points higher than on-medication scores. * subject is a surgical candidate in the event of a complication related to this procedure, class asa i or ii. * subject agrees to participate and signs consent form. exclusion criteria: * patient is pregnant. * patient has hiatal hernia \> 3 cm. * presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (\>1 per week) or gas/bloat. * esophagitis grades iii or iv by savary criteria.or type c or d by los angeles classification . * barrett's esophagus with dysplasia. * patient has had a previous endoscopic (endocinch, stretta, enteryx, etc.) or surgical repair (nissen fundoplication, etc.) performed to treat gerd. * active medical condition that would preclude the subject from finishing this study. * abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis). * pathological changes in soft tissue that would prevent secure fixation of the eps implant. * presence of esophageal or gastric varices. * esophageal dysmotility as determined by manometry studies. * esophageal stricture.

Keywords: gastroesophageal reflux disease (gerd) ndo full-thickness plicator plicator endoluminal gerd therapy
cardio-oncology rehabilitation exercise

Conditions: Breast Cancer

Summary: women with breast cancer who are referred to the cardiac rehabilitation program at the toronto rehabilitation institute will be invited to enrol in this observational study. participants will take part in an established 16-week multimodal cardiac rehabilitation program (health program) at toronto rehabilitation institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. change in vo₂peak will be assessed using cardiopulmonary exercise test (cpet). traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.


Eligibility criteria:
inclusion criteria: * history of early-stage breast cancer (i-iii) * currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies) * able to communicate in english exclusion criteria: * pregnancy * metastatic disease (stage iv) * unable or unwilling to complete cardiopulmonary exercise test

Keywords: cardiac rehabilitation cardio-oncology cardiometabolic health cardiovascular disease risk